Cladribine After Natalizumab for Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for individuals with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (active SPMS). Researchers aim to understand the safety and effectiveness of cladribine tablets after prior treatment with natalizumab. The trial seeks participants who have used natalizumab for at least a year without recent flare-ups. As a Phase 4 trial, this research provides insights into how the already FDA-approved treatment benefits more patients, offering valuable information for potential participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have been on certain treatments like corticosteroids, cytokine treatments, or certain immunosuppressive therapies recently. It's best to discuss your specific medications with the trial team.
What is the safety track record for cladribine?
Research has shown that cladribine is generally well-tolerated by people with multiple sclerosis (MS). In one study, 270 patients who took cladribine experienced fewer relapses and new brain lesions, indicating the treatment works well without causing major side effects. Another report found that cladribine does not increase the risk of serious health problems, even with additional treatment courses. Importantly, no evidence suggests that cladribine increases the risk of problems during pregnancy. Overall, these findings suggest cladribine is a safe option for managing MS symptoms.12345
Why are researchers enthusiastic about this study treatment?
Most treatments for multiple sclerosis, like interferons and glatiramer acetate, focus on modulating or suppressing the immune response to prevent flare-ups. Cladribine is unique because it targets specific immune cells, specifically lymphocytes, by reducing their numbers over time, helping to prevent the immune system from attacking the nervous system. Researchers are excited about cladribine because it is taken orally in a convenient tablet form, unlike some existing treatments that require injections or infusions. Additionally, cladribine's dosing schedule is less frequent, potentially improving patient adherence and quality of life.
What evidence suggests that cladribine might be an effective treatment for multiple sclerosis?
Research has shown that cladribine, which all participants in this trial will receive, effectively treats multiple sclerosis (MS). Studies have found that cladribine tablets significantly reduce relapses and decrease the size and number of new brain lesions in MS patients. In a 4-year study, nearly 9 out of 10 patients with relapsing MS did not experience disease progression. Additionally, cladribine lowered levels of a protein that signals nerve damage. Overall, these findings suggest that cladribine can be a strong option for managing MS symptoms and slowing the disease's progression.16789
Who Is on the Research Team?
Olaf Stuve, MD, PhD
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with relapsing forms of Multiple Sclerosis, including RRMS and active SPMS, who have been on natalizumab therapy for at least a year. Participants must weigh over 40 kg, not be pregnant or breastfeeding, use contraception effectively, and have no recent MS relapses. Exclusions include HIV or hepatitis infection, TB history, immunocompromised status, certain prior treatments like myelosuppressives or live vaccines recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout
A washout period of 14 to 28 days after the last infusion of natalizumab before starting cladribine treatment
Treatment Year 1
Participants receive cladribine 10 mg tablets in two cycles during the first year
Treatment Year 2
Participants receive cladribine 10 mg tablets in two cycles during the second year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension
Participants may opt into a 2-year extension study with no intervention, monitoring clinical and paraclinical disease activity
What Are the Treatments Tested in This Trial?
Interventions
- Cladribine
Trial Overview
The study tests the safety and effects of cladribine tablets in patients previously treated with natalizumab. It aims to understand how cladribine impacts the disease's progression and immune response in those with Multiple Sclerosis after switching from another treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All study participants will receive treatment with cladribine 10 mg tablets at the recommended cumulative dose of 3.5 mg/kg, divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). This regimen corresponds to the recommended dosage as per the USPI. Each treatment course is divided into 2 treatment cycles: * Administration of first treatment course (year 1 treatment): * First cycle: Starts on Day 1 of the study * Second cycle: Administered 23 to 27 days after the last dose of first cycle. * Administration of second treatment course (year 2 treatment): * First cycle: Administered at least 43 weeks after the last dose of year 1 treatment * Second cycle: Administered 23 to 27 days after the last dose of first cycle of year 2 treatment. The cycle dosage will be administered as 1 or 2 cladribine 10 mg tablets daily over 4 or 5 consecutive days.
Cladribine is already approved in United States, European Union for the following indications:
- Hairy cell leukemia
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
- Multiple sclerosis
- Hairy cell leukemia
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
EMD Serono
Industry Sponsor
Dr. Shepard
EMD Serono
Chief Medical Officer since 2021
MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics
Miguel Fernández Alcalde
EMD Serono
Chief Executive Officer
Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School
Published Research Related to This Trial
Citations
Cladribine tablets in the new multiple sclerosis era - PMC
Several recent studies have demonstrated the efficacy of CladT in reducing serum NfL (sNfL) levels over a 2-year treatment period in RRMS ...
The real-world efficacy of Cladribine tablets and treatment ...
In conclusion, the probability of first relapse was high in this nearly nationwide cohort of Finnish subjects treated with cladribine tablets for highly active ...
Effectiveness and safety of cladribine in MS: Real-world ...
Results: Among 270 patients treated with cladribine, we observed a profound reduction of both relapses and new or enlarging MRI lesions.
4.
emdserono.com
emdserono.com/us-en/company/news/press-releases/new-mavenclad-4-year-data-highlighting-durable-effects.html2025-09-17 New MAVENCLAD 4-year data highlighting ...
Four-year data show nearly 9 in 10 RMS patients remained free from progression independent of relapse activity (PIRA); Results highlight the ...
A real-world, single Centre study considering a two-year ...
Our experience provides information for the 2-years after the last dose of CLAD, confirming a higher effectiveness of CLAD when placed early in the treatment ...
Safety and efficacy of cladribine in multiple sclerosis
Our analysis showed that the PFS after cladribine use is 79% (95%CI 71%, 86%). Also, 58% of patients with MS who received cladribine remained ...
146. Post-Approval Safety of Cladribine Tablets in the ...
While data are currently scant, there is no evidence for an increased risk of adverse pregnancy outcomes in patients receiving cladribine tablets. Recommended ...
Cladribine tablets as therapy for advanced relapsing- ...
Discussion: The results indicate that CladT is effective and safe in Polish patients with RRMS, characterized by high disease activity, delayed ...
First insights into the safety and effectiveness of additional ...
Administering additional cladribine courses is an effective option to maintain disease control and did not trigger any serious adverse events attributable to ...
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